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BioWorld MedTech Perspectives

FDA or optimism: The worst of all possible worlds

A story of bureaucratic overreach, clinical trial data disclosure, and Washingtonian flights of fancy with a tip ‘o the hat to Voltaire.

In a castle of Silver Springalia, belonging to the Baron of Our-Way-or-the-Highway, lived an industrious youth endowed with the most inventive of manners. The old servants of the Baron preferred that the youth, named Indeed!, be the supplicant of the Baron, needful of the Baron’s approval in all things. The youth was expected to address the Baron as “oh Lord!” and laugh agreeably at all the Baron’s impetuous declarations.

The Preceptor Panglossover, a professor of meta-analytical-governmental-causation, was the instructor of the youth, and Panglossover said: “Indeed! It is demonstrable that things cannot be otherwise than as they are decreed; for all being created by the Baron for an end, all is necessarily for the best end.”

However, Indeed! found himself in a rapturous state with a mere handmaiden of the Baron, Cunecessity de Commerce, whose handkerchief was prized by all. Cunecessity unwittingly dropped her handkerchief once in plain view, whereupon Indeed! duly retrieved the necessary and secret item.

Cunecessity touched his hand and they sensed a connection of utmost urgency, one requiring the most tender guarding of their secrets, without which their relationship would wither and the kingdom would suffer for want of little Cunecessities and Indeeds!

However, the handkerchief was prized by the Baron, too, who demanded that Cunecessity de Commerce let fall the handkerchief in plain view of all, and thus put an end to this vile denial of the greater good. Indeed! proclaimed, “oh Lord!”

Indeed! beseeched the Baron “please, reconsider. What you propose is beyond the charge bestowed upon thee by the King’s Council of 535! Even the holy writs of Fidazia do not countenance this!” the inventive youth cried out.

However, the Baron, who had passed near their goings-on and beheld this pernicious cause and effect, chased the inventive youth from the castle with great kicks on the backside, bellowing, “Indeed! you shall have no secrets with Cunecessity in my kingdom!

Thus driven from a paradise, Indeed! wandered, and was conscripted into a force for the King of the O-U-S-ians, whereupon he was dealt 30 blows with a cudgel for the poor performance of his duties. He escaped from the forces of the O-U-S-ians, only to find himself in a dark alley, face-to-face with Panglossover, who was in a downtrodden state.

“Alas!” said Panglossover to his star pupil. “Indeed! do you no longer know your dear Panglossover?"

Upon recognizing his former tutor, Indeed! cried out, “what misfortune has happened to you?” He inquired further, “what has become of Miss Cunecessity de Commerce?”

“She is dead,” replied Panglossover. Indeed! nearly fainted, but mused after having regained his senses, “ah, best of worlds, where art thou? But of what illness did she die? Was it not for grief, upon seeing the Baron kick me out of his magnificent castle?”

“No,” said Panglossover, “she was ripped open by the O-U-S-ian soldiers, after having been violated by many. They broke the Baron's head for his feeble, half-hearted attempt to defend her,” he answered. At this discourse Indeed! nearly fainted again; but snapped out of it and inquired into the cause and effect, as well as into the sufficient reason that had reduced Panglossover to so miserable a plight and led to the demise of his beloved Cunecessity.

“Alas!” said the other, "it was transparent love; love of sharing, the comfort of the human species at the expense of common sense. Love, tender love,” Panglossover replied.

Panglossover continued: “It was unavoidable, a necessary ingredient in the best of worlds; for if Columbus had not in an island of America caught this disease of innovation, we should have neither chocolate nor cochineal.”

“This distemper is like religious controversy, confined to a particular spot for now,” Panglossover said, shaking his shaggy head. “The O-U-S-ians, the Asiaticans, know nothing of it; but there is a sufficient reason for believing that they will know it in their turn in a few centuries.”

“In the meantime, it has made marvelous progressiveness among us, especially in those great armies composed of honest well-disciplined Silver Springalian hirelings, who decide the destiny of states,” Panglossover said. “For we may safely affirm that when an army of ten thousand Silver Springalians fights another of an equal number, there are about nine thousand of them who are SOL on the other side,” he sadly concluded.